Carotid Stenting Certification

Carotid Stenting Certification

Disclosures Founding Board Member ICACSF SVIN Representative to ICACSF No financial interest

Intersocietal Accreditation Commission (IAC) Accreditation is IAC s only business for 23 years Over 15,000 sites accredited One non profit 501(c)(6) organization with seven divisions Five diagnostic imaging modalities (vascular testing, echo, nuclear/pet, MR and CT) Two therapeutic (carotid stent; vein center) Overall organization directed by IAC board Composed of 2 representatives from each division Responsible for strategic direction and financial oversight Primary division responsibility review and revise modality specific standards

IAC Carotid Stenting ICACSF Sponsoring Organizations American Academy of Neurology (AAN) American Association of Neurological Surgeons/Cerebrovascular Section American Association of Physicists in Medicine (AAPM) American Society of Neuroradiology (ASNR) Neurocritical Care Society (NCS) Society for Vascular Medicine (SVM) Society for Vascular Surgery (SVS) Society of Interventional Radiology (SIR) Society of NeuroInterventional Surgery (SNIS) Society of Vascular and Interventional Neurology (SVIN)

ACE- Accreditation for Cardiovascular Excellence Cath/PCI and Diagnostic Catheterization Accreditation CAS is newest Sponsors SCAI ACC 3 Centers Accredited

IAC Standards for Carotid Stenting Accreditation

IAC Requirements Volume criteria (25 facility; 15 individual physician) Medical and technical staff training and experience Procedure Log ( 3 years) Outcome data analysis Quality Improvement program (minimum 6 month review) Physicist report of the angiographic equipment Safety processes 5 procedures to include continuum of care processes and imaging Improving health care through accreditation

QI program requirements Review at a minimum every 6 months Outcome Measures ( risk category/indications and technical) Administrative Processes Technical (equipment) Physician Performance Patient and Staff Exposure Medical and Technical Staff Training and Experience Requirements A process/protocol for the performance of CAS procedures (recommended)

Procedure data elements Patient identifier Date of procedure Clinical Indication Symptomatic or asymptomatic Right or left procedure 30-day outcome for stroke and/or death for each patient Name of the primary operator Department or specialty of primary operator Use of embolic protection

Benchmark Outcome Analysis Criteria Only patients treated with CAS for indications of carotid bifurcation disease 2 to atherosclerosis, post CEA restenosis, or radiation induced stenosis included in the benchmark analysis Emergent procedures combined with intracranial acute ischemic stroke revascularization, CAS for trauma or dissection not included in the benchmark analysis but included in the overall QI program.

Benchmarks: Technical Outcomes Successful Deployment Benchmark = > 95% of the cases have successful stent deployment (if the stent has been deployed across the target lesion per the IFU) Improvement in the degree of Stenosis - percentage angiographic stenosis using NASCET criteria Benchmark = > 95% of the cases have improvement in the degree of stenosis.

Benchmarks: Technical Outcomes Independent neurological exam Benchmark: 100% at 24 hours for pre and post procedure measurement of NIHSS and mrs (if a change > 2 a neurological consult is required) 30 day follow up Benchmark: 80% of patients will have 30-day outcomes follow-up data -- Imaging of stent must be performed at 30 days +/-10 days) for patency. Duplex ultrasound is the recommended imaging study. -- Measurement of neurological outcome mrs; NIHSS

Benchmark: Complications Asymptomatic < 3% all stroke and death within 30 days of the procedure Symptomatic < 6% all stroke and death within 30 days of the procedure

Procedure Image Review Pre-procedure stenosis measurement and documentation using electronic calipers and image capture of the measurement is requested. Pre-stent frontal (AP) and Lateral subtracted views of the arterial phase of the intracranial vasculature to extend from the top to base of skull. The frontal view should extend to the lateral margin of the skull on the side of the angiogram. Post-stent frontal (AP) and Lateral subtracted views of the arterial phase of the intracranial vasculature to extend from the top of the skull to the base of skull. The frontal view should extend to the lateral margin of the skull on the side of the angiogram. The degree of stenosis post procedure.

Procedure Documentation Indication for intervention Requirements Noninvasive diagnostic exam reports (duplex, CTA, MRA) Invasive exam pre procedure report (cerebral angiography) H&P documentation Carotid stent procedure report Nurse and anesthesia monitoring report during the procedure Neurologic assessment (NIHSS and mrs) documentation pre and post procedure Patient 30-day follow-up results including NIHSS, mrs and neurological assessment Reports from imaging test performed at 30 day follow up

Program Data Summary 8 facilities (35 procedures reviewed) Asymptomatic reported volume: 653 Symptomatic reported volume: 321 Physician specialties (as reported) Interventional Radiology Cardiology Interventional Cardiology Vascular Surgery Neuro-Interventional Radiology Radiology Surgery

Program Data Summary Complications Stroke and death complication rate 1.99% Asymptomatic 2.49% Symptomatic All complications 3.52% Asymptomatic 7.88% Symptomatic

Program Summary Data Deficiencies 35 procedures reviewed 18 asymptomatic; 17 symptomatic Over estimation of stenosis (subjective vs. quantitative) NIHSS and mrs not consistently performed Patients not returning for 30 day follow up Neurological assessment not performed at 30 days Analysis performed incorrectly including other studies that do not meet benchmark criteria Percentage of complications not calculated correctly

Program Summary Data Deficiencies CAS not part of overall QI program Procedure log issues total calculations not accurate; some missing all items requested (clinical indication, designation asymp vs. symp) Radiation safety/image quality issues

Lessons Learned The IAC accreditation program assesses not only outcomes but appropriateness of intervention and accuracy of measurement of stenosis Findings: The degree of stenosis is frequently overcalled in routine and even research practice Raises concerns about the appropriateness of patient selection and overuse of intervention Raises concerns that outcomes may look misleadingly good if pts with 50% stenosis are being called 80-90% and being treated, since lower degrees of stenosis are usually associated with lower complication rates

IAC Standards % Stenosis Baseline ipsilateral carotid and cerebral angiography must be performed The percent of carotid artery stenosis should be measured using NASCET criteria. The use of electronic calipers, (if available on the system) is required to quantitatively measure the percent of the stenosis to validate the clinical necessity for the procedure

IAC Standards % Stenosis A process to confirm the accuracy of the percentage of stenosis reported for symptomatic and asymptomatic patients warranting the intervention must be in place If electronic calipers are used to measure the stenosis percentage, there must be a process to assess differences between subjectively reported and the electronic measurement. the quantitative (electronic) and subjective measures of stenosis severity should be very similar or identical. If subjective measurements are used to determine the need for treatment, deviations between the subjective and electronic measurement warrant a documented explanation and where appropriate, documented corrective action. Benchmark: 90% of patients should meet facility defined clinical and degree of stenosis indications as defined in the QI program

Comparison of IAC & ACE Quality Measure NIHSS/mRS certification Independent Neuro exam ACE No > 50% compliance IAC Yes 100% compliance NIHSS pre/peri/ 30 days 90% compliance 100% compliance Neurologist exam for changes No Yes (if NIHSS > 2)

Comparison of IAC & ACE Quality Measure Outcomes ACE IAC pre discharge 30 day 1 year S/D benchmark S/D/MI 80% NIHSS/mRS S/D/MI 50% S/D 80% Yes, not threshold no 3/6%? All vs. major 3/6 % all strokes Tech/Nurse Credentials No Yes

Comparison of IAC & ACE Quality Measure Radiation safety Mechanism for low volume On Site visit ACE air kerma <5 Gy No Yes, nurse MD for outliers IAC DAP, fluorotime Yes Clinical staff/md available Accreditation cycle Fee 2 years 3 years(mid site visit) $15,000 $6000

Comparison of IAC & ACE Quality Measure ACE IAC Physician Credentials Indications QI meetings Detector size(min) Angio success Stroke rescue Procedure success Societal Societal CMS 90% use CMS criteria Monthly; 75% Every 6 mos(min) 12 inches 9 inches <50% residual; 90% improvement;95% Require process Require process No comp;90% no

BENEFITS OF ACCREDITATION

Accreditation means the facility: Has undergone a thorough review of its operational and technical components by a panel of experts. Has standards in place for patient and personnel safety. Upholds processes that are in compliance with national standards. Has successfully passed a comprehensive site visit and facility audit

Accreditation Benefits Provides a standard of care for patients comparing one facility to another Provides independent, unbiased, outcome-based evidence to patients and their families that they are receiving the highest quality care Certifies to insurers that their beneficiaries are getting the best possible care Establishes the evidence necessary to support the image facilities would like to promote to the public Validates facility s position, voice, and influence in government policy-making circles

Accreditation Benefits Potentially minimizes liability by encouraging best practices and early identification and resolution of problems and offering evidence of meeting best practice standards in the event of a lawsuit Reduces costs by supporting more effective and efficient operation based on uniform standards Minimizes complications, which in turn benefits payors, patients, and society by reducing costs

IAC Accreditation Contact Information 800.838.2110 Nancy Merrill: nmerrill@intersocietal.org Mary Lally: lally@intersocietal.org ACE Accreditation 202.657.6859 Mary Heisler, RN BA: info@cvexcel.org